Dilating Drops: Patient Safety and Liability Risks

Dilating drops are used on countless patients daily during diagnostic examinations and surgical procedures. They are essential in order to obtain an adequate view of the retina and fundus. Indeed, failure to perform a thorough examination of the eye could lead to significant patient harm such as delay in diagnosis or failure to diagnose, as well as surgical complications due to poor visibility.

See OMIC’s  risk management recommendation guide below.

Dilating Drops

Dilating DropsDiscuss Potential Side Effects of Eye Drops

Information Regarding Dilating Eye Drops (for the patient) 

Making Your Office Safe

Case Study – Patient Slip and Fall Following Dilation

Safe Medical Devices Act: Reporting Requirements and Risk Management Concerns

By Pamela S. Schremp, RN, MSN, CRNO

[Argus, September, 1992]

A new law mandating the reporting of injuries resulting from defective medical devices is generating concern among ophthalmologists, risk managers and others that the reports could be interpreted as an admission of liability by the user.

The Safe Medical Devices Act of 1990 (SMDA) (Public Law 102-629) requires ambulatory surgery centers, hospitals, outpatient diagnostic centers and other user facilities to report all incidents in which a medical device or user error may have caused or contributed to the death, serious injury or serious illness of a patient. Physicians’ offices are exempt from reporting such incidents, but surgicenters such as those run by many ophthalmologists are not. Additionally, the new law’s interim guidelines require that user error by, for example, an ophthalmologist working in a hospital must be reported.

All reports filed under the SMDA are available for public disclosure under the Food and Drug Administration’s (FDA) Freedom of Information Act, although information that constitutes an invasion of personal privacy is presumably deleted from the report prior to its release. However, the FDA recognizes that submission of a report is not necessarily an admission that the submitter, the device, the facility or its employees caused or contributed to the event being reported. The law does state that reports are not admissible into evidence unless the report contains false information and the facility, individual or physician filing the report knew this information was false.

Reports, however, can be obtained by a plaintiff’s attorney and possibly used as background information to build a case. To protect against this, reports should include a disclaimer indicating that it is submitted “in accordance with the Safe Medical Devices Act (21 CFR 803.32 (c)) and does not constitute an admission that the device, the reporting facility or its employees caused or contributed to the event which is the subject of the report.”

User facilities have always had the option to voluntarily report such events to the manufacturer. However, prior to November 1991, when the SMDA took effect, few reports were ever filed. Consequently, the federal government enacted mandatory reporting by user facilities to assist in the detection of defective medical devices and assure their rapid removal from the market.

Final regulations for the SMDA have not yet been promulgated. Tentative final rules were issued in November 1991, with broad definitions that left room for interpretation. For example, a “device” refers to any instrument, apparatus, implement, machine, in vitro reagent or other related article intended for use in the diagnosis or treatment of a patient (21 USC 331 (h)). Under this definition, most equipment used by ophthalmologists, including lasers, microscopes, tonometers and intraocular lenses, is subject to SMDA requirements.

“Serious injury or illness” means those injuries that are life threatening, result in permanent body function impairment or permanent damage to a body structure, or necessitate immediate medical or surgical intervention to prevent permanent body function impairment or permanent damage to a body structure (21 CFR 803.3) (r). The last phrase of the definition has created confusion and left room for interpretation.

Examples of ophthalmic related incidents that presumably must be reported under the SMDA include removal or exchange of an intraocular lens due to pseudophakic bullous keratopathy, severe corneal ulcer in an extended wear contact lens patient requiring hospitalization, and laser beam reflection causing a burn to a resident wearing the wrong goggles in a hospital-sponsored eye clinic. Even though the observer wore the wrong goggles, the last example is reportable as user error under the SMDA’s tentative final rules. The rules included user error to assist the manufacturer in obtaining information that might make the device safer or easier to use.

Reports must be submitted to the manufacturer within 10 working days after the facility becomes aware of information that reasonably suggests a possibility that a device may have caused or contributed to the death, serious injury or serious illness of a patient of the facility. If the manufacturer is unknown, the event must be reported to the FDA. Events in which a device may have caused or contributed to a patient’s death must be reported to the FDA as well as to the manufacturer. The user facility must also submit a semiannual summary of previously reported events to the FDA by Jan. 31 and July 31 of each year.

Even though final regulations for the SMDA have not yet been released, tentative rules are in effect, and all ophthalmologists are advised to become acquainted with them. To obtain a copy, contact OMIC, 655 Beach Street, San Francisco, CA 94109.

Ophthalmologists who own or manage ambulatory surgery centers should establish policies and procedures for determining if an event is reportable and for sequestering equipment (including disposables such as tubing) that may have been involved in a reportable event until its safe use can be assured. These policies should address:

• To what extent will the center investigate the event?
• How and under what circumstances will the device be released to the manufacturer?
• Who will be responsible for putting the SMDA into operation, including recordkeeping and report submission? Be sure to include a disclaimer statement in every SMDA report submitted to the manufacturer and to the FDA.

Will FDA Regulations Preempt Personal Injury Suits?

By Elizabeth C. Moran, JD

[Digest, Winter, 1996]

In January 1996, the U.S. Supreme Court agreed to decide whether FDA regulation of medical devices precludes patients from bringing strict liability, negligence, and other common law claims for injuries caused by improper design, manufacture, or labeling of medical devices.

In Lohr v. Medtronics, Inc., the plaintiff claimed she was injured by an unsafe pacemaker, a Class III device which had been marketed under the abbreviated Section 510(k) procedure as “substantially equivalent” to previous pacemakers.

Applying the Medical Device Amendments of the Food, Drug and Cosmetic Act, which prohibit states from imposing regulations on medical devices that are “different from or in addition to” federal regulations, the U.S. Court of Appeals for the Eleventh Circuit determined that because the FDA imposed specific regulations on the manufacture and labeling of the device, injured patients cannot sue the manufacturers for manufacturing defects or inadequate warnings. The Court held, however, that claims relating to improper design of the pacemaker still could be pursued because the FDA had not imposed any specific requirements governing design.

Over the past several years, the courts have issued widely divergent and conflicting decisions in this area. For example, the Ninth Circuit recently held, in Kennedy v. Collagen Corp., that the Medical Device Amendments do not preclude personal injury suits at all but are intended to prevent states from enacting statutes and regulations that apply specifically to medical devices.

Some courts have held that certain kinds of injury claims are preempted for Class III devices that have gone through full Pre-Market Approval, but not for devices, such as Class II devices, that are subject to lesser regulation. Other courts have held that there is no preemption unless the FDA has enacted regulations specific to a particular device, such as the specific requirements for warnings on tampons and hearing aids. Still others have applied the doctrine of preemption broadly, concluding that the FDA’s general requirements for manufacturing procedures and labeling, which apply to all medical devices regardless of classification, preclude most, if not all, common law injuries.

The Supreme Court’s decision will have a profound effect upon the scope of litigation involving medical devices.

If the Court applies preemption broadly, as many lower courts have done, device manufacturers will be largely insulated from liability. However, the physician who uses the device remains a potential defendant — perhaps the only “deep pocket” — under theories of medical negligence and lack of informed consent.

Message from the Chairman –Cost of Avastin

When the Centers for Medicare &

Medicaid Services (CMS) announced earlier this year that Medicare reimbursement for Bevacizumab (Avastin®) would decrease from $35 to $7 a dose, it sent shock waves through the retina community. Although ophthalmologists, like other physicians, have grown accustomed to lower fee

reimbursements across the board, this particular action posed such a significant threat to our ability to provide care to our patients that it was imperative it be reversed.

Major ophthalmic societies, including the American Academy of Ophthalmology, the American Society of Retina Specialists, the Macula Society, and the Retina Society, united in a coordinated effort to convince Medicare to reverse the decision. Key members of OMIC’s Board, including Dr. David W. Parke II, CEO of the American Academy of Ophthalmology, and Dr. George A. Williams, a leading retina surgeon at William Beaumont Hospital in Royal Oak, MI, contacted Medicare officials to help educate those involved of the unintended consequences of such a fee decrease. Ironically, these included increased cost to Medicare if doctors suddenly switched to Lucentis and millions of elderly patients were unable to afford the copayment for this much more expensive drug.

This is where OMIC’s risk management team excelled in communicating with ophthalmologists about this issue. OMIC’s 2007 recommendations for intravenous Avastin warned practitioners that the drug must be prepared by a licensed and trained professional in a compounding or hospital pharmacy to avoid the liability risks associated with off-label ophthalmic use.

Coming from the nation’s largest insurer of ophthalmologists and retinal subspecialists and disseminated via OMIC.com, one of the most frequently visited ophthalmic websites in the u.S., OMIC’s recommendations were influential. In concert with other actions initiated by the AAO and the three retina societies, OMIC provided background information that helped in the effort to persuade CMS to reverse its decision. In November, CMS directed practitioners to “return to their previous reporting practice for small intraocular doses of Bevacizumab (Avastin®) furnished prior to October 1, 2009.”

Dr. William L. Rich, AAO’s Medical Director for Health Policy, expressed it best, “The AAO, all three retinal societies, Congress, and our patients are all very thankful for this reversal. It benefits patients, doctors, and taxpayers.”

I am proud of OMIC’s role in the success of this collective endeavor. When we work together, we can achieve significant advancements for the ophthalmic community and our patients. We can reduce our risks, minimize threats to our livelihood, and protect the quality of care for our patients. Victories such as this are not just “feel good” stories about ophthalmologists working together to effect change, but also examples of the strategic and financial advantages we have gained by creating our own ophthalmic malpractice carrier.

Richard L. Abbott, MD OMIC Chairman of the Board

Floppy Iris Syndrome

A syndrome named intraoperative floppy iris syndrome or IFIS has been linked to a medication called Flomax, which is prescribed for men with prostatic hypertrophy and women with urinary retention.

Click here to link to an AAO article by Dr.David F. Chang that gives recommendations on how to prepare for and manage it.